NCT07833852Enrolling by invitation
Long-Term Immune Persistence After Bivalent HPV Vaccination in Females From Study 311-HPV-1005
A Single-Center, Open-Label, Long-Term Extension Study to Evaluate Immune Persistence Following Vaccination With a Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) in Healthy Females Aged 9 to 30 Years at Enrollment in Study 311-HPV-1005
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
This is a single-center, open-label, prospective observational extension of Study 311-HPV-1005 (NCT04965350). The study follows females who received at least one dose of a bivalent human papillomavirus vaccine containing HPV-16 and HPV-18 L1 virus-like particles in the base study. No vaccine is administered in this extension. Participants in the immunogenicity persistence subset provide blood samples at Months 42 and 66 after the first dose in the base study for measurement of HPV-16 and HPV-18 neutralizing antibodies. Participants eligible for the breakthrough-case cohort are followed for HPV-related cervical disease, including HPV-16- or HPV-18-related cervical intraepithelial neoplasia grade 2 or worse.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 486 (estimated)
- First submitted
- 16 Sept 2026
- Start date
- 30 Aug 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- NCT number
- NCT07833852
What you commit to
- Study type: Observational
- Planned participants: 486
- From 30 Aug 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of any other HPV vaccine during Study 311-HPV-1005 or between completion of the base study and enrollment in this extension.
Lab values
- At a visit involving blood collection, any condition that may interfere with venipuncture, including a platelet count below 20 x 10\^9/L, phlebitis, or hemophilia.
Other
- Any other factor that, in the investigator's judgment, makes the participant unsuitable for the study.
Who the study is looking for
- Previously enrolled in Study 311-HPV-1005 (NCT04965350) at the Mianyang Center for Disease Control and Prevention.
- Received at least one dose of the bivalent HPV vaccine in the base study.
- For the immunogenicity persistence subset: completed all three doses in the base study and had valid neutralizing antibody results before vaccination and one month after the third dose.
- For the breakthrough-case cohort: at least 18 years of age at extension-study enrollment or becoming 18 years of age during the extension study.
- Participant provided written informed consent; for a participant younger than 18 years at extension-study enrollment, the participant and at least one parent or legal guardian provided written informed consent or assent as required.
- Able to understand and comply with the study procedures. Participants in the immunogenicity persistence subset agreed to blood collection at Months 42 and 66. Participants in the breakthrough-case cohort agreed to scheduled remote or site follow-up and to provide relevant HPV- and cervical-disease information.
Age in the registry: 12 years to 34 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mianyang Center for Disease Control and Prevention Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.